Clinical trial Recruiting at 14 sites Phase 1 Interventional Ages 18 and up

KQB368 as a single-drug treatment for adults with advanced solid tumors

Official title: A Phase 1/1b, Open-label, Multicenter, Dose Escalation and Dose Expansion Study Evaluating the Safety, Tolerability, Pharmacokinetics and Efficacy of KQB368 in Participants With Advanced Solid Malignancies With KRAS G12S or G12C Mutations

Run by Kumquat Biosciences Inc. · NCT07542704 · Data updated 2026-11-12

This study tests whether taking KQB368 by mouth every day can help shrink tumors and is safe for adults with advanced solid cancers.

More Advanced Solid Tumors trials

Quick facts

PhasePhase 1
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment48 (estimated)
SponsorKumquat Biosciences Inc.
Industry-sponsored
Locations14 sites (Los Angeles, California and 13 other locations)
StatusRecruiting
StartedMay 27, 2026
Main results expectedDecember 2029
Study endsDecember 2029
Registry record updatedNovember 3, 2026
Trial IDNCT07542704 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults with unresectable or metastatic solid tumors, specifically those with KRAS G12C or KRAS G12S mutations, who have measurable disease and adequate organ function.

Probably not a fit

Patients whose tumors do not respond to KQB368 or who experience intolerable side effects may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1, interventional study to evaluate KQB368 as a monotherapy in adults with advanced solid malignancies, including colorectal cancer, non-small cell lung cancer, uterine cancer, and cancers with KRAS G12C or G12S mutations. The primary goals are to determine a safe starting dose, observe changes in tumor size, and understand how the drug is processed by the body. Participants will take KQB368 orally in 21-day cycles and visit the clinic regularly during the first 5 weeks, then at the start of each subsequent cycle. The study will monitor safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity using RECIST v1.1 criteria.

Why it matters

Potential benefit: Participants may experience tumor shrinkage or disease stabilization if the drug is active, contributing to the understanding of KQB368’s potential.

How similar studies have gone: Phase 1 trials of similar targeted agents have shown safety signals and early activity in solid tumors, but this specific agent is novel and its efficacy is still being explored.

Who can join: the full rules

Show full inclusion / exclusion criteria
* Histologically confirmed diagnosis of a solid tumor
* Malignancy with either a KRAS G12C or KRAS G12S mutation
* Unresectable or metastatic disease
* No available treatment with curative intent
* Adequate organ function
* Measurable disease per RECIST v1.1
* Must be able to swallow with no GI condition that prevents absorption

Where it's running

  • START Los Angeles
    Los Angeles, California, United States
    Recruiting
  • Massachusetts General Hospital
    Boston, Massachusetts, United States
    Recruiting
  • Karmanos Cancer Institute
    Detroit, Michigan, United States
    Recruiting
  • John Theurer Cancer Center at Hackensack UMC
    Hackensack, New Jersey, United States
    Recruiting
  • Memorial Sloan Kettering Cancer Center
    New York, New York, United States
    Recruiting
  • UH Cleveland Medical Center
    Cleveland, Ohio, United States
    Recruiting
Show 8 more locations
  • Providence Cancer Institute
    Portland, Oregon, United States
    Recruiting
  • Fox Chase Cancer Center
    Philadelphia, Pennsylvania, United States
    Recruiting
  • SCRI Oncology Partners
    Nashville, Tennessee, United States
    Recruiting
  • NEXT Oncology Austin
    Austin, Texas, United States
    Recruiting
  • START Dallas Fort Worth
    Dallas, Texas, United States
    Recruiting
  • START San Antonio
    San Antonio, Texas, United States
    Recruiting
  • University of Utah - Huntsman Cancer Institute
    Salt Lake City, Utah, United States
    Recruiting
  • NEXT Oncology Virginia
    Fairfax, Virginia, United States
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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    This study tests ABBV-253 to see if it is safe, how it affects the cancer, and how the drug moves in the body for adults with advanced solid tumors.

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  • FL-261 imaging to detect and stage c-MET–expressing cancers

    This first-in-human test uses FL-261 labeled for PET or SPECT to see if it safely highlights c-MET–positive tumors in adults with advanced solid tumors such as non-small cell lung, colorectal, or head and neck cancer.

    Recruiting Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Wuhan, Hubei · NCT07510321

  • First-in-human test of CKD-703 for advanced solid tumors and non-small cell lung cancer

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    Recruiting Phase 1/2 Chong Kun Dang Pharmaceutical · Ohio City, Ohio · NCT07439094

  • BPI-572270 in RAS-mutant advanced solid tumors (including NSCLC, CRC, PDAC)

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    Recruiting Phase 1/2 Betta Pharmaceuticals Co., Ltd. · Blacktown, New South Wales and 6 other locations · NCT07435038

  • Combining RAS(ON) inhibitors with ivonescimab for adults with RAS‑mutant advanced solid tumors

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    Recruiting at 19 sites Phase 1/2 Revolution Medicines, Inc. · Scottsdale, Arizona and 18 other locations · NCT07397338

  • RMC-5127 for advanced cancers with KRAS G12V mutation

    This trial will test whether the experimental drug RMC-5127, alone or with daraxonrasib or cetuximab, helps adults with advanced KRAS G12V-mutant solid tumors.

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.